cap nostics web prospectus (llc) (2013 05-30)

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Opportunity to create a New Company (CapNostics, LLC) to re-launch the FDA cleared swallowable screening device for esophageal bottle-brush cellular retrieval for use with new Genome Sequencing diagnostic tests (Biomarkers) that are expected to become mass out-patient screening tests used early detection of Barrett’s Esophagus, H.Pylori and other diseases. Prepared by: Martin von Dyck E-mail: [email protected] http://www.CapNostics.com May 30, 2013 FDA Cleared Ready to Launch!

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CapNostics, LLC seeks to launch its FDA Cleared non-endoscopic gastric/esophageal specimen collection device.

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Page 1: Cap nostics web prospectus (llc) (2013 05-30)

Opportunity to create a New Company (CapNostics, LLC) to re-launch the FDA cleared swallowable screening device for esophageal bottle-brush cellular retrieval for use with new Genome Sequencing diagnostic tests (Biomarkers) that are expected to become mass out-patient screening tests used early detection of Barrett’s Esophagus, H.Pylori and other diseases.

Prepared by:Martin von Dyck

E-mail: [email protected]://www.CapNostics.com

May 30, 2013

FDA Cleared

Ready to Launch!

Page 2: Cap nostics web prospectus (llc) (2013 05-30)

2

Disclaimer• This “Presentation”, together with any information enclosed or accompanying it, contains restricted, privileged and

confidential information and is therefore intended solely for distribution to authorized persons. If you are not the intended recipient of this Presentation, you must not disseminate, modify, copy or take action in reliance upon it, unless expressly authorized by CapNostics, LLC This Presentation may not be used, reproduced or transmitted, in any form or by any means whatsoever, without permission from BE Holdings, LLC

• Confidentiality Notice: This Business Plan is confidential and contains proprietary information and intellectual property of CapNostics, LLC Neither this Business Plan nor any of the information contained herein may be reproduced or disclosed under any circumstances without the express written permission of CapNostics, LLC This Business Plan does not constitute an offer to sell or solicitation of an offer to buy securities of CapNostics, LLC . Any such offers and sales will be made only to “Accredited Investors,” as defined in Regulation D under the Securities Act of 1933, as amended, pursuant to separate agreements to be negotiated by the parties.

• This Presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties, including discussion of product and business plans, current asset valuations as well as financial estimates and projections. These statements are based on Ornaki’s expectations, estimates, projections and assumptions. You can identify these statements by the fact that they do not strictly to historic or current facts. They use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, “forecast” and similar words in connection with any discussion of future operating or financial performance. Due to various risks and uncertainties, actual events or results may differ materially from those reflected or contemplated in such forward looking statements.

• Neither CapNostics, LLC, nor any of its employees or representatives, make any warranty or representation, whether express or implied, or assumes any legal liability or responsibility for the accuracy and completeness of any information disclosed in this Presentation.

Page 3: Cap nostics web prospectus (llc) (2013 05-30)

What is Barrett’s esophagus

• Gastroesophageal reflux is a normal physiologic event, which occurs in all individuals. However, when this occurs frequently and an individual develops recurrent symptoms and/or complications, it is considered gastroesophageal reflux disease (GERD). It is estimated that GERD affects up to 30 million people in the U.S., with 10% of those individuals experiencing symptoms on a daily basis.

• Barrett's esophagus is a disorder in which the lining of the esophagus (the tube that carries food from the throat to the stomach) is damaged by stomach acid and changed to a lining similar to that of the stomach.

• Barrett's esophagus occurs more often in men than women. You are more likely to have this condition if you have had GERD for a long time.

• Patients with Barrett's esophagus may develop more changes in the esophagus called dysplasia. When dysplasia is present, the risk of getting cancer of the esophagus increases.

• Early detection and treatment is highly desirable as this is a potentially lethal malignancy.• If the cancer is detected at an early stage, the 5 year survival is 83–90%, compared with a dismal 10–15% 5

year survival of late stage cancers. Barrett’s esophagus is present as a pre-malignant lesion in many or most cases of esophageal carcinoma.

• Data reflect a large number of individuals with Barrett’s esophagus who remain unrecognized until the endoscopy has been performed. Moreover, a 21-fold increase in the recognition of Barrett’s (from 22.6 cases per 100 000 population to 376 cases per 100 000 population) has also been reported when cases of Barrett’s oesophagus found during autopsy were compared with those that were clinically diagnosed, that is by endoscopy. Thus, recent data suggest that the prevalence of the Barrett’s esophagus may be much higher than had been originally appreciated.

Page 4: Cap nostics web prospectus (llc) (2013 05-30)

What is Barrett’s esophagus

• How Is Barrett's Esophagus Diagnosed?• Because there are often no specific symptoms associated with Barrett's esophagus, it can only be diagnosed with an upper

endoscopy and biopsy. In general, doctors recommend that people over the age of 40 who have a long-term history of GERD be screened for Barrett's esophagus.

• To perform an endoscopy, a doctor called a gastroenterologist inserts a long flexible tube with a camera attached down the throat into the esophagus after giving the patient a sedative. This is expensive with the National average being $2700 per procedure. (http://www.newchoicehealth.com/Directory/Procedure/126/Upper%20GI%20Endoscopy)

• Biomarkers (This what CapNostics,LLC will partner with)• Several new biomarkers that have recently been evaluated can potentially also help to identify a group of patients with a

high risk of developing HGD and cancer. Recent studies have found that in individuals who progressed from Barrett’s esophagus to esophageal carcinoma, one of two normal p53 alleles was inactivated by mutation and the second was lost by a mechanism termed as loss of heterozygosity (LOH). Reid and colleagues followed 256 patients with Barrett’s esophagus and p53 LOH data at baseline for up to 5 years and found p53 LOH to be a strong predictor of progression to esophageal carcinoma (relative risk 16; 95% CI 6.2 to 39; p<0.001).

• In another study, biopsy specimens from 11 of 12 patients with esophageal carcinoma stained positive for cyclin D1 and a statistically significant risk for progression to carcinoma (OR 6.85; 95% CI 1.57 to 29.91, p 0.0106) was found in the patients who stained positively for this biomarker. Systematic flow cytometry can identify patients with increased 4N or aneuploidy and has also been used in recent studies. A 28% 5 years cumulative esophageal cancer incidence was found in those Barrett’s patients with either aneuploidy or increased 4N compared to a 0% 5 year cumulative esophageal cancer incidence in patients with neither aneuploidy nor increased 4N fractions. As yet, none of the molecular markers has shown to be a better predictor or more cost effective than the finding of dysplasia on biopsy. Prospective multicenter validated studies need to be performed to provide more information regarding these predictors and their exact role in surveillance of Barrett’s esophagus patients.

Page 5: Cap nostics web prospectus (llc) (2013 05-30)

Current method of diagnosis vs CapNostics swallowable device

$2700 on average and quite unpleasant.

VS

Less than $100 and in Doctors office.

Page 6: Cap nostics web prospectus (llc) (2013 05-30)

Introduced in 1993 the device was on the market for 1.5 years and was withdrawn

due the lack of functional Biomarker

test kits.

20 years later, with the recent break-

through Biomarker Technology, the

world is ready for this non-endoscopic

option!

Page 7: Cap nostics web prospectus (llc) (2013 05-30)

CapNostics, LLCMISSION STATEMENT: To form company that will capitalize on the existing IP, FDA 510k cleared status

&Technical File. While remaining a virtual holding company, have the vital Cellular Retrieval

Device manufacturing outsourced and sell the FDA Approved Cellular Retrieval Device to genome sequencing (Biomarker) diagnostic testing companies to sell along with their Biomarker Kits.

Several Biomarker companies are eager to place orders for the Cellular Retrieval devices once they become available.

7

Est. Sales Price$20 each

Page 8: Cap nostics web prospectus (llc) (2013 05-30)

Device isFDA Cleared !

On January 20, 2000: All Biosearch Medical

Products, Inc.’s rights to this product and it’s FDA

510K were formally transferred to

Martin von Dyck.

Page 9: Cap nostics web prospectus (llc) (2013 05-30)

Publishedin 1992

Page 10: Cap nostics web prospectus (llc) (2013 05-30)

Instructions for use.

INSTRUCTIONS:No scope, swallow method

1) Give the patient a drink of water at room temperature, except when medically contraindicated.

2) Allow the patient to swallow the capsule. Gently advance the stylus to follow the capsule, as with a nasogastric feeding tube. (The atraumatic distal deflector tip is radiopaque, placement confirmation can be achieved via fluoroscopy or X-ray.)

3) Allow time for the gelatin capsule to dissolve and the foam sphere to be completely exposed. This will

normally occur after 2 - 4 minutes at normal body temperature. Five (5) minutes should assure uniform withdrawal in all patients.

(Swallowing some warm water will accelerate this process.) 4) CAUTION : Withdraw the foam sphere at once if substernal

pressure or dysphagia develops during passage of the device.

5) After confirmation of position, gently and slowly withdraw the foam sphere from the patient by pulling the stylus. 6) Amputate the foam sphere from the stylus assembly.

7) Transfer the collected cells from the foam sphere by imprinting the foam onto slides. Or swirl the foam sphere in saline (for immediate transport to pathology) or appropriate solution for Cytology, Cytometry. WARNING : Contraindicated for documented esophageal dysfunction that could preclude safe passage of endoscope or capsule.

Page 11: Cap nostics web prospectus (llc) (2013 05-30)

In-Vivo Endoscopic view of the Capnostics Swallowable

Specimen retrieval device.Video still shots show the Capsule dissolving in the stomach

and then collecting cells through the Lower Esophageal sphincter and throughout the Esophagus.

Sample shown is a 25mm, 40ppi foam version.

Page 12: Cap nostics web prospectus (llc) (2013 05-30)

Foam collector expanding as gelatin capsule dissolves

Very flexible polyester

monofilament for strength and

comfort.

Page 13: Cap nostics web prospectus (llc) (2013 05-30)

Foam collector expanding as gelatin capsule dissolves

Page 14: Cap nostics web prospectus (llc) (2013 05-30)

Foam collector 75% expanded.

Page 15: Cap nostics web prospectus (llc) (2013 05-30)

Foam collector 90% expanded.

Observe the special molded radiopaque distal retention fitment This will prevent the foam sphere from disconnecting.

Page 16: Cap nostics web prospectus (llc) (2013 05-30)

Foam sphere easily passes through esophageal sphincter.

Page 17: Cap nostics web prospectus (llc) (2013 05-30)

Fully deployed! White material is cellular material being collected

Page 18: Cap nostics web prospectus (llc) (2013 05-30)

Fully deployed! White material is cellular material being collected

Page 19: Cap nostics web prospectus (llc) (2013 05-30)

Copy Cat Product (CytoSponge)verifies that our version has merit

'Sponge on string' trial launched to try and prevent deadly oesophageal cancer25 Jul 2011

Cancer Research UK has launched a large multi-centre trial to test a new device for detecting Barrett's oesophagus – a condition that puts sufferers at increased risk of developing cancer of the oesophagus, one of the most deadly cancers.In the last thirty years oesophageal cancer rates have risen dramatically in the UK compared with many other Western countries, particularly for a certain type called adenocarcinoma, which is linked to Barrett's oesophagus.The trial will examine whether a promising new test called 'cytosponge' could provide an improved method of identifying patients with Barrett's oesophagus, so they can be offered treatment to reduce their risk of oesophageal cancer.The test involves patients swallowing a small capsule with a string attached, which dissolves in the stomach and expands to form a 3cm sponge.The sponge is gently drawn back out using the string, removing a small sample of the cells lining the oesophagus as it passes, which can be tested in the lab for early signs of cancer.Each test should cost just £25, compared with £400 for a traditional endoscopy, and the procedure is far less invasive.Chief Investigator Dr Rebecca Fitzgerald, who led the Cambridge-based team that developed the cytosponge test, said: "If this trial is successful it will provide a cheap, safe and highly effective method of identifying people with Barrett's oesophagus, so they can take steps to reduce their risk of developing cancer."This would open the doors for a national screening programme, much like those offered for breast, cervical and bowel cancers, to help prevent oesophageal cancer among the one to two people in every 100 with Barrett's oesophagus who go on to develop the disease."Oesophageal cancer is the sixth most common cause of death from cancer in the UK, with around 7,500 people dying from the disease each year. It is often diagnosed at a late stage, making it difficult to treat, and this largely accounts for the poor survival rates.Persistent heartburn or indigestion, caused by stomach acid coming back up the gullet, is a major risk factor for cancer of the oesophagus. Over time this can cause the cells lining the lower oesophagus to start to resemble those found in the small and large intestines, a condition known as Barrett's oesophagus.But if the condition can be diagnosed before cancer develops, patients can be offered closer monitoring and treatment to help remove abnormal cells.At present the condition can only be detected by 'endoscopy' – a relatively expensive procedure which involves putting a camera down the throat to collect a sample of the cells the lining the oesophagus for analysis under the microscope.Most patients with heartburn symptoms take medication without ever having an endoscopy, meaning cases of Barrett's oesophagus often go undiagnosed.Dudley Hedge, 71, from Cambridge, has been involved with the cytosponge trial. He said: "It is important to get a diagnosis quickly and I was happy to be on the trial. Having the cytosponge was a relatively straightforward procedure and I would definitely encourage others to take part."Earlier pilot studies, funded by the Medical Research Council, found that patients significantly preferred cytosponge compared to endoscopy. This latest study will look more closely at the accuracy of the test and identify new biomarkers for diagnosing the different grades of Barrett's oesophagus more reliably.Kate Law, director of clinical trials at Cancer Research UK, said: "Oesophageal cancer is one of the most difficult cancers to detect and treat, with only eight per cent of people with the disease surviving over five years. Hopefully this trial will provide a simple means of screening people for Barrett's oesophagus on a much larger scale, so those at high risk can be offered closer monitoring and measures to help prevent them developing this devastating form of cancer."

Barrett's Esophagus

Page 20: Cap nostics web prospectus (llc) (2013 05-30)

MANAGEMENT TEAM, FOUNDERS & DIRECTORS

Martin von Dyck Co-Founder and CEO/President of CapNostics

• Martin von Dyck with over 25 years of Medical Device experience is President functioning as special start-up and launch advisor to CapNostics.

• Presently, he is also the Executive Vice President – Operations with Hydromer, Inc. and is the President of Biosearch Medical Products, Inc. (a wholly owned subsidiary) . Hydromer is Publically Traded Bio-chemical company specializing in various market sectors and acquired all outstanding shares of the publically trade Biosearch Medical Products, Inc. in 2000. Martin was the President and Board Member of Biosearch Medical Products who initiated and consummated the merger.

• He has personally designed, filed FDA 510k submissions and successfully launched numerous medical devices such as Nasogastic Feeding Catheters, Percutaneous Gastrostomy catheters, Mass Cellular Retrieval and Biopsy devices, Bi-polar electrocoagulation devices for Intestinal lesions and others for treatment of hemorrhoids, Laparoscopically placed Jejunostomy catheters, Urological Catheters, Laparoscopic Instruments, Electronic Biofeedback Devices for incontinence and constipation and many others.

• Simultaneously managed multiply medical device manufacturing facilities while under strict US FDA and ISO quality guidelines.

• Identified and successfully negotiated numerous medical company acquisitions and divestitures maintaining SEC compliance and improving shareholder value.

• In addition to negotiating domestic OEM and Private Label manufacturing and distribution agreements with such companies as C.R. Bard, Baxter, Olympus, Conmed, Wilson-Cook, U.S. Endoscopy, Tyco Medical, Medinol, Boston Scientific, Johnson & Johnson, etc. , Martin has negotiated complex multiple two and three party Cross-Border Technology License Agreements with Royalty Components. USA, EU, China, Japan.

Page 21: Cap nostics web prospectus (llc) (2013 05-30)

MANAGEMENT TEAM, FOUNDERS & DIRECTORS

Elena McGuire, M.D.; Vice President of Sales and Marketing and Business Development

• Currently with Hydromer, Inc. and it’s Biosearch Medical Products, Inc. subsidiary, she manages the highly profitable and innovative Medical Coatings strategic business units which services the domestic and international medical device industries.

• Responsible for managing product development from a customer request, through the R&D process, the manufacturing, to the delivery to the end user.

• Develop marketing strategies, organizing, and attending trade shows in the US, China and Europe.

• Negotiating the Coating Services and Supply Support Agreements with transfer the Coating Technology to the customers facility.

• Developed distribution network in Asia and Europe.

• Manage a team of 10 people of R&D bio-chemists, engineers, coating specialists, and 12 production operators.

“Due to her prior experience as a Physician, Pediatrician (Russian Federation) as well as a Project, Sales, Marketing Manager, Business Development in the Medical Device Industry, Elena has solid knowledge and clear vision of the Healthcare, the Global Market, its major tendencies, and Medical Device needs and applications. I enjoyed be involved in developing novel approaches or new projects for improving Medical Device capabilities and features for increasing and growing commercial opportunities.”

Page 22: Cap nostics web prospectus (llc) (2013 05-30)

2nd Marketing Opportunity: Helicobacter pylori

• Helicobacter pylori ; H. pylori, previously named Campylobacter pyloridis, is a Gram-negative, microaerophilic bacterium found in the stomach. It was identified in 1982 by Barry Marshall and Robin Warren, who found that it was present in patients with chronic gastritis and gastric ulcers, conditions that were not previously believed to have a microbial cause. It is also linked to the development of duodenal ulcers and stomach cancer. However, over 80 percent of individuals infected with the bacterium are asymptomatic and it has been postulated that it may play an important role in the natural stomach ecology.

• More than 50% of the world's population harbor H. pylori in their upper gastrointestinal tract.

• Infection is more prevalent in developing countries, and incidence is decreasing in Western countries.

Page 23: Cap nostics web prospectus (llc) (2013 05-30)

Current tests for Helicobacter pylori

• According to the NIH, There are several different methods to test for H. pylori infection.

• Breath test (called the carbon isotope-urea breath test or UBT):• Up to 2 weeks before the test, the patient must stop taking any antibiotics, bismuth-containing

medications such as Pepto-Bismol, and proton pump inhibitors (PPIs).• The patient swallows a special substance containing urea (a waste product the body produces as it breaks

down protein) that has been made harmlessly radioactive.• If H. pylori are present, the bacteria convert the urea into carbon dioxide, which is detected and recorded

in the patient's exhaled breath after 10 minutes.• This test can identify almost all people who have H. pylori and confirm that the H. pylori infection has been

fully treated.

• Blood tests:• Blood tests are used to measure antibodies to H. pylori, and the results are reported in minutes.• This test is not quite as accurate as the other tests.• These blood tests can be used to diagnose whether an H. pylori infection is present. However, the test

cannot determine whether you have an infection at the time of the test or how long you have had it because the test remains positive for years even if the infection is cured. As a result, it cannot be used to see if the infection has been eradicated.

Page 24: Cap nostics web prospectus (llc) (2013 05-30)

Current tests for Helicobacter pylori

• According to the NIH, There are several different methods to test for H. pylori infection.

• Stool test:• A test to detect the genetic traces of H. pylori in the feces appears to be as accurate as the

breath test for initially detecting the bacteria, and for detecting recurrences after antibiotic therapy.

• This test can also be used to diagnose the infection and confirm that the H. pylori infection has been eradicated.

• Biopsy:• The most accurate way to identify the presence of H. pylori is by taking a tissue biopsy from

the lining of the stomach. The only way to do this is with endoscopy, which is an invasive but safe procedure.

• A biopsy will be done if endoscopy was needed for other reasons. This includes diagnosing the ulcer, treating any bleeding, or making sure cancer is not present. Otherwise, many patients are treated for H. pylori based on one of the three noninvasive tests listed above.

Page 25: Cap nostics web prospectus (llc) (2013 05-30)

Copy Cat Product (CytoSponge)verifies that our version has merit

INTRODUCTION/OBJECTIVES:Benign conditions of the esophagus are common and are either treated empirically with acid-suppressants or investigated by endoscopy when symptoms are significant and a definitive diagnosis is warranted. The Cytosponge (Lao-Sirieix Gut 2009) has the potential to diagnose a range of conditions (oesophagitis, eosinophilic oesophagitis, lymphocytic gastritis, candidiasis and H.pylori infection) from a single sample and would have significant benefits for patients (less invasive and more acceptable than endoscopy) and health care providers (cost-effective, rapid diagnostic information without referral to secondary care).

AIMS & METHODS:We aimed to determine if benign esophageal and gastric pathologies can be diagnosed using the Cytosponge and associated assays. Samples from a prospective multicentre primary care cohort comprising 504 males and females aged 50 to 70 with a history of reflux symptoms (Kadri BMJ 2010) were used. All individuals had a Cytosponge test followed by upper GI endoscopy within 6 weeks at which any pathology was noted according to standard criteria and biopsies were taken from any abnormal areas and for CLO test when clinically indicated. Cytosponge samples were analysed for inflammatory cells, yeast and bacteria using haematoxylin and eosin stained sections and immunostaining for H. pylori. Inflammation was scored according to predefined criteria.

RESULTS:Full data set was available for 464 individuals including 263 patients with no findings by either endoscopy or Cytosponge and 103 cases with negative endoscopies and findings on the Cytosponge (table 1). Of particular note, 1 cardia cancer case, missed by endoscopy, was identified on the Cytosponge sample. Overall, inflammatory conditions were diagnosed more readily on the Cytosponge with 95 extra patients being diagnosed with significant inflammation either by lymphocytic, neutrophil or eosinophilic infiltrate or by the presence of ulcer slough. Similarly, 7 further patients were diagnosed with candidiasis by the Cytosponge alone. 20 CLO tests were performed and 7 out of the 7 positive tests were confirmed by the Cytosponge.

CONCLUSION:The Cytosponge and associated tests have the potential to diagnose benign oesophageal pathologies and H.pylori infection. A larger clinical study is warranted to confirm the utility of the Cytosponge in this setting.

NON-ENDOSCOPIC DIAGNOSTIC TESTS FOR ESOPHAGEAL DISEASES AND H.PYLORI USING THE CYTOSPONGE Pierre Lao-Sirieix (October 22, 2012)

H.PYLORI